Letrozole

Generic Name: Letrozole

Brand Names: Femara, Kisqali Femara Co-pack

Drug Type: Small Molecule

Chemical Formula: C_₁₇H_₁₁N_₅

CAS Number: 112809-51-5

Unique Ingredient Identifier: 7LKK855W8I

Background: Letrozole, or CGS 20267, is an oral non-steroidal type II aromatase inhibitor first described in the literature in 1990. It is a third generation aromatase inhibitor like exemestane and anastrozole, meaning it does not significantly affect cortisol, aldosterone, and thyroxine.

Letrozole was granted FDA approval on 25 July 1997.

Indication: Letrozole is indicated to treat postmenopausal women with hormone receptor (HR) positive early breast cancer, postmenopausal women with early breast cancer who have periviously been treated with tamoxifen, and postmenopausal women with HR+ or unknown advanced breast cancer. Letrozole, given with ribociclib, is indicated to treat pre, peri, and postmenopausal women with HR+ and human epidermal growth factor 2 (HER2) negative advanced or metastatic breast cancer.

Associated Conditions: Advanced Breast Cancer, Anovulatory cycle, Epithelial Ovarian Cancer, HR+, HER2-, Advanced Breast Cancer, Stage I Breast Cancer, Metastatic HR + HER2 - breast cancer

Clinical Trials

Combined Chromium With Letrozole Versus Letrozole Only in Induction of Ovulation in Patients With Polycystic Ovary Syndrome

Completed

Conditions: Polycystic Ovary Syndrome

Interventions: Drug: Letrozole with chromium

First Posted Date: 2023-03-13

Last Posted Date: 2023-03-15

Lead Sponsor: Cairo University

Target Recruit Count: 90

Registration Number: NCT05765305

Locations: 🇪🇬
Faculty of medicine, Cairo, القاهره, Egypt

A Randomized Study Comparing the Immune Modulation Effect of Ribociclib, Palbociclib, and Abemaciclib in ER+/HER2- EBC

Phase 2

Recruiting

Conditions: Breast Cancer
Hormone Receptor-positive Breast Cancer
Hormone Therapy

Interventions: Drug: Palbociclib
Drug: Ribociclib
Drug: Abemaciclib
Drug: Letrozole

First Posted Date: 2023-03-13

Last Posted Date: 2023-03-16

Lead Sponsor: National Taiwan University Hospital

Target Recruit Count: 60

Registration Number: NCT05766410

Locations: 🇨🇳
Department of Oncology, National Taiwan University Hospital, Taipei City, Taiwan
🇨🇳
Department of Oncology,National Taiwan University Hospital, Taipei, Taiwan

Comparison of Letrozole With Lerociclib Versus Letrozole With Placebo Control in Patients With Advanced/Metastatic or Recurrent, Grade 1 or Grade 2 Endometrial Cancer

Phase 3

Withdrawn

Conditions: Endometrial Carcinoma

Interventions: Drug: Lerociclib
Drug: Letrozole 2.5mg
Drug: Placebo

First Posted Date: 2023-02-06

Last Posted Date: 2023-11-03

Lead Sponsor: EQRx International, Inc.

Registration Number: NCT05712941

Study of Narazaciclib (ON 123300) Plus Letrozole in Endometrial Cancer and Other Gynecologic Malignancies

Phase 1

Recruiting

Conditions: Endometrioid Endometrial Cancer

Interventions: Drug: Narazaciclib
Drug: Letrozole 2.5mg

First Posted Date: 2023-01-30

Last Posted Date: 2023-12-12

Lead Sponsor: Traws Pharma, Inc.

Target Recruit Count: 60

Registration Number: NCT05705505

Locations: 🇺🇸
NYU Langone, New York, New York, United States
🇺🇸
Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas, Texas, United States
🇺🇸
Arizona Oncology Associates, PC - HOPE, Tucson, Arizona, United States

and more 5 locations

Letrozole vs Clomiphene Citrate for Induction of Ovulation in Women With Polycystic Ovarian Syndrome

Phase 2

Completed

Conditions: Polycystic Ovary Syndrome
Infertility

Interventions: Drug: letrozole 2.5mg-7.5mg
Drug: Clomiphene Citrate 50mg-150mg

First Posted Date: 2023-01-27

Last Posted Date: 2023-01-27

Lead Sponsor: Services Institute of Medical Sciences, Pakistan

Target Recruit Count: 220

Registration Number: NCT05702957

Locations: 🇵🇰
Services Institute of Medical sciences, Lahore, Punjab, Pakistan

Letrozole in Uterine Leiomyosarcoma

Phase 2

Recruiting

Conditions: Uterine Leiomyosarcoma

Interventions: Drug: Letrozole

First Posted Date: 2022-12-14

Last Posted Date: 2024-12-19

Lead Sponsor: GOG Foundation

Target Recruit Count: 40

Registration Number: NCT05649956

Locations: 🇺🇸
University of Colorado Cancer Center - Anschutz Cancer Pavilion, Aurora, Colorado, United States
🇺🇸
Endeavor Health - Kellogg Cancer Center, Evanston, Illinois, United States
🇺🇸
University of Massachusetts Memorial Medical Center, Worcester, Massachusetts, United States

and more 9 locations

Safety Extension Study for Subjects With HR+, HER2- Breast Cancer for Subjects Who Have Completed the OVELIA Study

Phase 3

Conditions: Breast Cancer

Interventions: Drug: TOL2506
Drug: Tamoxifen
Drug: Letrozole tablets
Drug: Anastrozole Tablets
Drug: Exemestane Tablets

First Posted Date: 2022-12-09

Last Posted Date: 2025-05-02

Lead Sponsor: Tolmar Inc.

Target Recruit Count: 250

Registration Number: NCT05645536

Locations: 🇺🇸
Texas Oncology - Central South, Austin, Texas, United States
🇧🇷
Irmandade Santa Casa de Misericordia de Porto Alegre, Porto Alegre, Rio Grande Do Sul, Brazil
🇺🇸
Marin Cancer Care, Inc., Greenbrae, California, United States

and more 22 locations

Pyrotinib Combined With Trastuzumab, Dalpiciclib, Letrozole Versus TCbHP (Trastuzumab Plus Pertuzumab With Docetaxel and Carboplatin) as Neoadjuvant Treatment in HR +/HER2 + Breast Cancer

Phase 2

Recruiting

Conditions: Breast Cancer

Interventions: Drug: Pyrotinib
Drug: Trastuzumab
Drug: Pertuzumab
Drug: Dalpiciclib
Drug: Docetaxel
Drug: Carboplatin
Drug: Letrozole
Drug: Gonadotropin-releasing hormone agonist

First Posted Date: 2022-12-06

Last Posted Date: 2023-03-20

Lead Sponsor: Shengjing Hospital

Target Recruit Count: 236

Registration Number: NCT05638594

Locations: 🇨🇳
Shengjing Hospital of China Medical University, Shenyang, Liaoning, China

Letrozole for Estrogen/Progesterone Receptor Positive Low-grade Serous Epithelial Ovarian Cancer (LEPRE Trial)

Phase 3

Recruiting

Conditions: Carcinoma, Ovarian Epithelial
Low Grade Serous Adenocarcinoma of Ovary

Interventions: Drug: Letrozole tablets
Drug: carboplatin AUC 5 and paclitaxel 175 mg/m2

First Posted Date: 2022-11-01

Last Posted Date: 2025-01-27

Lead Sponsor: Ente Ospedaliero Ospedali Galliera

Target Recruit Count: 132

Registration Number: NCT05601700

Locations: 🇮🇹
Ospedale San Donato, Arezzo, AR, Italy
🇮🇹
Ospedale degli Infermi, Ponderano, BI, Italy
🇮🇹
Ospedale San Martino, Belluno, BL, Italy

and more 15 locations

Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy

Phase 2

Recruiting

Conditions: Breast Neoplasm
HER2-positive Breast Cancer
HER2-negative Breast Cancer
Hormone Receptor Positive Tumor
Breast Cancer
Breast Tumors
Hormone Receptor Negative Tumor
Triple-Negative Breast Cancer (TNBC)
Locally Advanced Breast Cancer
Early-stage Breast Cancer

Interventions: Drug: Nab paclitaxel
Drug: Camrelizumab
Drug: Pyrotinib
Drug: SHR-A1811
Drug: SHR-A1921
Drug: Pertuzumab
Drug: SHR-1316
Drug: Dalpiciclib
Drug: Trastuzumab
Drug: Goserelin
Drug: Carboplatin
Drug: Apatinib
Drug: Letrozole
Drug: Famitinib
Drug: Epirubicin
Drug: Cyclophosphamide
Drug: Fluzoparib

First Posted Date: 2022-10-17

Last Posted Date: 2024-12-27

Lead Sponsor: Fudan University

Target Recruit Count: 716

Registration Number: NCT05582499

Locations: 🇨🇳
Fudan University Shanghai Cancer Center Shanghai, China, 200032, Shanghai, Shanghai, China

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